Description du projet
Développement d’une plateforme de fabrication de biotraitements intelligents pour les thérapies cellulaires autologues
Les immunothérapies autologues ont permis d’obtenir des résultats de traitement impressionnants chez les patients atteints de cancers du sang. La prochaine génération d’immunothérapies personnalisées inclura des lymphocytes infiltrant les tumeurs (TIL pour «tumour-infiltrating lymphocytes») afin de surmonter les limites de la thérapie adaptative dans le traitement des tumeurs solides. En adoptant des technologies analytiques innovantes et des systèmes de contrôle de processus intelligents, le consortium SMARTER, financé par l’UE, entend développer une plateforme de biotraitement de premier ordre pour les thérapies cellulaires autologues personnalisées. Ce projet tire parti de la découverte de nouveaux biomarqueurs du processus d’expansion des cellules T et de nouveaux capteurs de spectroscopie de fluorescence pour la surveillance des paramètres du processus de bioproduction des TIL. Son objectif est de construire la plateforme prototype qui soutiendra le développement ultérieur du bioréacteur à l’échelle commerciale.
Objectif
Autologous immunotherapies have revolutionised cancer treatment providing impressive survival benefits in patients with blood cancers. The next generation of personalised immunotherapies using tumour-infiltrating lymphocytes (TIL) aims to overcome efficacy limitations of CAR-T therapies in the treatment of solid tumours. Lack of effective, fast, adaptive, controllable and scalable manufacturing process remains one of the critical bottlenecks for clinical adoption of such complex personalised cell therapies.
In the SMARTER project, Achilles Therapeutics UK Limited, a clinical-stage company developing autologous cell therapies, partners with the centre of excellence for Cell and Gene Therapy Catapult and academic experts in process biomarker discovery (Instituto de Investigacion Sanitaria La Fe) and bioprocess sensor development (Leibniz Universitat Hannover). The consortium aims to develop a first-in-class, smart bioprocessing manufacturing platform for personalised autologous cell therapies, implementing for the first time in-line process analytical technologies and smart process control systems. The project exploits breakthrough discoveries of novel T cell expansion process biomarkers and development of new fluorescence spectroscopy sensors for real-time monitoring of critical process parameters, toa enable adaptive process control of the precision TIL biomanufacturing process. After the project, the prototype R&D platform will be ready for follow-up development of the commercial scale bioreactor in GMP environment.
The SMARTER platform will critically improve production efficiency, reduce overall costs-of-goods, shorten manufacturing cycle times (shorter vein-to-vein time), decrease batch failures and lead to more consistent and predictable cell therapy product quality. Finally, the innovations will enable clinical implementation of a potential breakthrough personalised adoptive cell therapy for hardest-to-treat solid tumours such as lung cancer and melanoma.
Champ scientifique
- medical and health sciencesmedical biotechnologygenetic engineeringgene therapy
- medical and health sciencesclinical medicineoncologylung cancer
- medical and health sciencesclinical medicineoncologyskin cancermelanoma
- medical and health sciencesbasic medicineimmunologyimmunotherapy
- medical and health sciencesmedical biotechnologycells technologies
Programme(s)
- HORIZON.3.1 - The European Innovation Council (EIC) Main Programme
Thème(s)
Régime de financement
HORIZON-EIC - HORIZON EIC GrantsCoordinateur
30167 Hannover
Allemagne